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Accelerated Approval Reform Proposals Worry Industry: ‘Science Doesn’t Move The Same Way’

 
• By Derrick Gingery

During House hearing, PhRMA and BIO highlight provisions of PDUFA VII agreement that the associations say would benefit the pathway more than the additional reforms being considered by Congress.

Cartier Esham at House Energy and Commerce Health Subcommittee
BIO's Cartier Esham testifies about accelerated approval and other FDA reforms during a House Energy and Commerce Health Subcommittee hearing. • Source: Screenshot

Industry representatives did not offer overwhelming support to many of the accelerated approval reforms offered by lawmakers, and their hesitancy suggests it will be more difficult to include the proposed changes in the upcoming user fee legislation.

Members of the House Energy and Commerce Health Subcommittee were looking for stakeholder support for dueling bills that would make changes to the expedited approval pathway during a 17 March hearing

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